The rate and extent of drug absorption are a function of many factors, including the site of administration, the physiochemical characteristics of the compound, and the dosage form. The issues involved in bioequivalence and bioavailability are enmeshed in controversy, which is compounded by issues of therapeutic efficacy and equivalence as well as by economic factors. Sixteen contributions discuss study design, species differences, and regulatory perspectives worldwide. Annotation copyright Book News, Inc. Portland, Or.
The rate and extent of drug absorption are a function of many factors, including the site of administration, the physiochemical characteristics of the compound, and the dosage form. The issues involved in bioequivalence and bioavailability are enmeshed in controversy, which is compounded by issues o
"Bioequivalence and Its Determination Bioequivalence and Therepeutic
Equivalence, Rober L. Williams Study Design for the Assessment of
Bioavailability and Bioequivalence, Francis L. S. Tse, William T. Robinson,
and Miles G. Choc Statistical Criteria, Carl M. Metzler Influence of Disease
on Bioavailability, Wolfgang A. Ritschel and Donald D. Denson Factors
Influencing Bioavailability and Bioequivalence, Arzu Selen The Role of
Intestinal Metabolism on Bioavailability, William H. Barr Bioavailability of
Transdermal and Topical Dosage Forms, Marvin C. Meyer In Vitro Methods to
Determine Bioavailability: In Vitro-In Vivo Correlations, Peter G. Welling
SPECIAL DIFFERENCES Pharmacodynamic Models Animal Models for Oral Drug
Absorption, Jennifer B. Dressman and Kenji Yamada Interspecies Scaling in
Pharmacokinetics, Patrick J. McNamara Pharmacodynamic Models in
Bioequivalence, S. Thomas Forgue and Wayne A. Colburn Perspectives of
Regulatory Agencies, Worldwide, on Bioequivalence Testing Bioequivalence: A
United States Regulatory Perspective, Shrikant V. Dighe and Wallace P. Adams
Bioequivalence: A Canadian Regulatory Perspective, Iain J. McGilveray
Bioequivalence: A European Community Regulatory Perspective, A. G. Rauws
Bioavailability and Bioequivalence: An Australian Perspective, Susan Walters
and R. Rodney Charles Hall Bioequivalence: A Nordic Perspective, Tomas
Salmonson, Hans Melander, and Anders Rane "
